Show simple item record

dc.contributor.authorFuchs, CS
dc.contributor.authorMuro, K
dc.contributor.authorTomasek, J
dc.contributor.authorVan Cutsem, E
dc.contributor.authorCho, JY
dc.contributor.authorOh, S-C
dc.contributor.authorSafran, H
dc.contributor.authorBodoky, G
dc.contributor.authorChau, I
dc.contributor.authorShimada, Y
dc.contributor.authorAl-Batran, S-E
dc.contributor.authorPassalacqua, R
dc.contributor.authorOhtsu, A
dc.contributor.authorEmig, M
dc.contributor.authorFerry, D
dc.contributor.authorChandrawansa, K
dc.contributor.authorHsu, Y
dc.contributor.authorSashegyi, A
dc.contributor.authorLiepa, AM
dc.contributor.authorWilke, H
dc.identifier.citationJournal of gastric cancer, 2017, 17 (2), pp. 132 - 144
dc.description.abstractPurpose To identify baseline prognostic factors for survival in patients with disease progression, during or after chemotherapy for the treatment of advanced gastric or gastroesophageal junction (GEJ) cancer.Materials and methods We pooled data from patients randomized between 2009 and 2012 in 2 phase III, global double-blind studies of ramucirumab for the treatment of advanced gastric or GEJ adenocarcinoma following disease progression on first-line platinum- and/or fluoropyrimidine-containing therapy (REGARD and RAINBOW). Forty-one key baseline clinical and laboratory factors common in both studies were examined. Model building started with covariate screening using univariate Cox models (significance level=0.05). A stepwise multivariable Cox model identified the final prognostic factors (entry+exit significance level=0.01). Cox models were stratified by treatment and geographic region. The process was repeated to identify baseline prognostic quality of life (QoL) parameters.Results Of 1,020 randomized patients, 953 (93%) patients without any missing covariates were included in the analysis. We identified 12 independent prognostic factors of poor survival: 1) peritoneal metastases; 2) Eastern Cooperative Oncology Group (ECOG) performance score 1; 3) the presence of a primary tumor; 4) time to progression since prior therapy <6 months; 5) poor/unknown tumor differentiation; abnormally low blood levels of 6) albumin, 7) sodium, and/or 8) lymphocytes; and abnormally high blood levels of 9) neutrophils, 10) aspartate aminotransferase (AST), 11) alkaline phosphatase (ALP), and/or 12) lactate dehydrogenase (LDH). Factors were used to devise a 4-tier prognostic index (median overall survival [OS] by risk [months]: high=3.4, moderate=6.4, medium=9.9, and low=14.5; Harrell's C-index=0.66; 95% confidence interval [CI], 0.64-0.68). Addition of QoL to the model identified patient-reported appetite loss as an independent prognostic factor.Conclusions The identified prognostic factors and the reported prognostic index may help clinical decision-making, patient stratification, and planning of future clinical studies.
dc.format.extent132 - 144
dc.titlePrognostic Factor Analysis of Overall Survival in Gastric Cancer from Two Phase III Studies of Second-line Ramucirumab (REGARD and RAINBOW) Using Pooled Patient Data.
dc.typeJournal Article
rioxxterms.typeJournal Article/Review
dc.relation.isPartOfJournal of gastric cancer
pubs.notesNot known
pubs.organisational-group/ICR/Primary Group
pubs.organisational-group/ICR/Primary Group/Royal Marsden Clinical Units
pubs.organisational-group/ICR/Primary Group
pubs.organisational-group/ICR/Primary Group/Royal Marsden Clinical Units
pubs.embargo.termsNot known
dc.contributor.icrauthorChau, Ianen

Files in this item


This item appears in the following collection(s)

Show simple item record
Except where otherwise noted, this item's license is described as